Takeda seeks FDA approval for diabetes drug

The drug combines pioglitazone HCl and glimepiride, a sulfonylurea, to directly target insulin resistance, a condition in which the body does not efficiently use the insulin it produces.

Glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. When used in combination, Glimepiride and pioglitazone can help patients with type 2 diabetes manage their blood glucose levels. The company is seeking approval to bring the medication to market in the US.

According to the American Diabetes Association, diabetes affects an estimated 18.2 million Americans. Type 2 diabetes is the most common form, and may account for about 90 to 95% of all diagnosed cases of diabetes.

Actos, an insulin sensitizer belonging to the thiazolidinedione (TZD) class of oral antidiabetic medications, directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels.

The drug should be taken once daily as an adjunct to diet and exercise, and is approved for type 2 diabetes for use as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin. However, the drug can cause fluid retention that may lead to or worsen heart failure in patients with a predisposition to such conditions.